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Efficacy and Safety Study of Ultrasound Bone Strength Device to Measure Calcaneal Bone Strength Index of Human Subjects

N

Nanjing Medical University

Status

Completed

Conditions

Clinical Trial
Equipment Safety
Comparative Effectiveness Research

Treatments

Device: SONOST3000
Device: Oste-scan 500A

Study type

Interventional

Funder types

Other

Identifiers

NCT02971527
HJHC-YLQX2016001

Details and patient eligibility

About

The purpose of this study is to examine whether ultrasound bone strength device (Model Number: Oste-scan 500A) is effective and safe in measuring calcaneal bone strength index of human subjects, compared with a listed, similar device (Model Number: SONOST3000).

Full description

This study adopt a method of multicenter, open-labeled, self-paired design. Each subject will be randomly assigned to two different detective sequence groups. In one group, the investigators will detect the same calcaneus of each subject by experimental ultrasound bone strength device firstly and then by control device. In another group, the investigators will detect the same calcaneus of each subject by control ultrasound bone strength device firstly and then by experimental device. Experimental ultrasound bone strength device is developed by Wuxi Huajian Hengchuang Medical Equipment Science and Technology Co., Ltd.. This device's model number is Oste-scan 500A and report number is Z-Y-2009-2014, Z-E-0530-2014(G). Control ultrasound bone strength device which has same clinical indications and action mechanism with the experimental one, is manufactured by Osteosys Co., Ltd.. This device's model number is SONOST3000.

Enrollment

150 patients

Sex

All

Ages

20 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Subject who need to measure calcaneal bone strength index.
  • Subject is a male or female subject 20-80 years of age.
  • Subject is willing and able to provide signed and dated written informed consent form.
  • Subject whose compliance is good and can cooperate to complete the clinical trial.

Exclusion criteria

  • Subject whose heel skin fester or defect.
  • Subject has a history of allergic reactions to ultrasonic coupling agent.
  • Subject who is not cooperative obviously or nervous extremely.
  • Pregnant or lactating females.
  • Subject has a mental disease, without self-control.
  • Subject has participated in other clinical trial within a month.

Trial design

Primary purpose

Screening

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

150 participants in 2 patient groups

Oste-scan 500A-SONOST3000
Experimental group
Description:
In this group, the investigators will measure calcaneal bone strength index of each subject by experimental device firstly and then by control device.
Treatment:
Device: Oste-scan 500A
Device: SONOST3000
SONOST3000-Oste-scan 500A
Experimental group
Description:
In this group, the investigators will measure calcaneal bone strength index of each subject by control device firstly and then by experimental device.
Treatment:
Device: Oste-scan 500A
Device: SONOST3000

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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